Drug Information |
ANDA Number | Generic Drug Name | Applicant | Tentative Approval Date | |
---|---|---|---|---|
1 | 75-710 | ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), 40 MG (BASE), AND 70 MG (BASE) | TEVA PHARMACEUTICALS USA | 12/27/02 |
2 | 65-105 | TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML VIAL | ROXANE LABORATORIES, INC. | 12/31/02 |
3 | 75-816 | CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML PACKAGED IN SINGLE-DOSE AMPULES | FAULDING PHARMACEUTICAL COMPANY | 12/31/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: January 2, 2003
Originator: OTCOM/DLIS
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